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Completed

NCT Number: NCT04897126

Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while the experimental group was treated with MUSK Pill 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age was 18-75 years old, and the gender was not limited;
  • The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), Within 1 year, coronary CTA or coronary angiography examination of coronary artery normal or lesions < 50%;
  • Willing to follow up and sign informed consent.

Exclusion criteria

  • Patients were selected and had no angina pectoris without medication
  • History of vascular reconstruction within 6 months, CABG or PCI;
  • Preparation for CABG or PCI during the trial period
  • The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination;
  • Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism;
  • There were three months of acute myocardial infarction;
  • Severe respiratory disease, COPD or active pulmonary infection;
  • Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period;
  • Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr > 1.5 times of normal value), active liver disease, cirrhosis or uremia patients;
  • Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness;
  • Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies;
  • Pregnant, lactating women and women and men with recent birth plans;
  • Allergic constitution or allergy to known components of the study drug;
  • The researchers judged that the patients who were not suitable for the study were not suitable.

(Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)

Treatment and study plan

Shexiang Baoxin pill(MUSKARDIA)

Radiation

On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.

Other names: routine treatment

Placebo

Radiation

On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.

Other names: routine treatment

Primary outcomes

  1. Changes of Seattle angina pectoris scale

    Time frame: 12 weeks ± 1 week

    Main evaluation indicators

Secondary outcomes

  1. Average number of angina attacks per week

    Time frame: 12 weeks ± 1 week

    Secondary evaluation index

  2. Changes in total dosage of sublingual nitroglycerin buccal tablets

    Time frame: 12 weeks ± 1 week

    Secondary evaluation index

  3. Changes of angina pectoris classification in CCS

    Time frame: 12 weeks ± 1 week

    Secondary evaluation index

  4. Incidence of major cardiovascular events (MACE)

    Time frame: 12 weeks ± 1 week

    Secondary evaluation index

  5. the incremental cost-effectiveness ratio (ICER) was used as the evaluation index

    Time frame: 12 weeks ± 1 week

    Pharmacoeconomic evaluation

Sponsors and collaborators

Lead sponsor

Shanghai Hutchison Pharmaceuticals Limited

Industry

Collaborators

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group
  • General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
  • Second Affiliated Hospital of Bengbu Medical College
  • Shanghai Changzheng Hospital
  • Shanxi Cardiovascular Hospital
  • Tangshan Central Hospital
  • The First Hospital of Hebei Medical University
  • The Second Affiliated Hospital of Jiaxing University
  • Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group
  • Zibo Municipal Hospital

Registry information

Official study title

Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Acronym: LESS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 21, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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